FDA Revises Education Blueprint for Opioid Prescribers
January 30, 2018 – The U.S. FDA has announced revisions to its “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain” as part of the administration’s efforts to reduce rates of new opioid addiction.
The Blueprint is a 13-page document that contains core content that must be made available to prescribers by drug manufacturers of both immediate-release and extended release/long-acting opioid analgesics. Revisions to the Blueprint include expanded information on: acute and chronic pain management; safe use of opioids and non-opioid or non-drug treatment options; and addiction medicine and opioid use disorders.
Unlike previous versions, the updated Blueprint is required to be offered not only to prescribers, but to nurses, pharmacists, and other healthcare professionals involved in pain management. The Blueprint will be used in conjunction with the FDA’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS).
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.